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EXTEND THE DEADLINES ESTABLISHED IN MINISTERIAL RESOLUTION NO. 554-2022/MINSA, WHICH APPROVED THE MANUAL OF GOOD PRACTICES FOR PHARMACEUTICAL OFFICES
El 23 de mayo de 2023, se publicó en el Diario Oficial “El Peruano” la Resolución Ministerial Nº 481-2023/MINSA, que aprobó el Documento Técnico: Manual de Buenas Prácticas de Oficina Farmacéutica. La presente Resolución Ministerial amplía, hasta el 28 de noviembre de...
PROVISIONS ARE ISSUED REGARDING THE GOOD MANUFACTURING PRACTICES (GMP) CERTIFICATE FOR THE REGISTRATION, RE-REGISTRATION, AND IMPORTATION OF PHARMACEUTICAL PRODUCTS
El 23 de mayo de 2023, se publicó en el Diario Oficial “El Peruano” el Decreto Supremo Nº 012-2023-SA, que dicta disposiciones referidas al Certificado de las BPM para la inscripción y reinscripción en el registro sanitario y en la importación de productos...
THE REGULATION THAT REGULATES THE PRESENTATION AND CONTENT OF THE DOCUMENTS REQUIRED FOR THE REGISTRATION AND RE-REGISTRATION OF BIOLOGICAL PRODUCTS IS APPROVED.
El 17 de mayo de 2022, se publicó en el Diario Oficial “El Peruano” el Decreto Supremo N° 011-2023-SA, que aprobó el Reglamento que regula la presentación y contenido de los documentos requeridos en la inscripción y reinscripción de productos biológicos: Otros...
THE DRAFT REGULATION REGULATES THE PRESENTATION AND CONTENT OF THE DOCUMENTS REQUIRED FOR THE REGISTRATION AND RE-REGISTRATION OF BIOLOGICAL PRODUCTS: OTHER BIOLOGICAL PRODUCTS ARE TO BE PUBLISHED.
On July 28, 2022, Ministerial Resolution N° 563-2022/MINSA was published in the Official Gazette "El Peruano", which provides for the publication of the draft Regulation that regulates the presentation and content of the documents required for the registration and re-registration of biological products: Other biological products.
MANUAL OF GOOD PHARMACEUTICAL OFFICE PRACTICES APPROVED
On July 27, 2022, Ministerial Resolution N° 554-2022/MINSA, which approves the Manual of Good Pharmacy Office Practices, was published in the Official Gazette "El Peruano".
ORDER THE PUBLICATION OF THE SUPREME DECREE PROJECT THAT UPDATE THE TECHNICAL PARAMETERS ON PROCESSED FOODS REGARDING THE CONTENT OF SUGAR, SODIUM AND SATURATED FATS, AND AMENDS THE REGULATION OF LAW N° 30021
On July 19, 2022, Ministerial Resolution No. 526-2022-MINSA was published in the Official Gazette "El Peruano", which provided for the publication of the draft Supreme Decree that proposes to update the technical parameters on processed foods references to sugar, sodium and saturated fat content, and modifies the Regulation of Law No. 30021, Law for the Promotion of Healthy Eating for children and adolescents, which was approved by Supreme Decree No. 017-2017-SA.
THE REGULATIONS REGULATING THE AUTHORIZATIONS FOR THE IMPORTATION OR ACQUISITION OF VACCINES AND MEDICINES AGAINST THE SARSCOV-2 CORONAVIRUS WITHIN THE FRAMEWORK OF THE PROVISIONS OF LAW NO. 31225 WERE APPROVED.
On July 12, 2022, Supreme Decree N° 014-2022-SA was published in the Official Gazette "El Peruano", which approved the Regulation that regulates the authorizations for the importation or acquisition of vaccines and medicines against the SARSCOV-2 coronavirus within the framework of the provisions of Law N° 31225.
ESTABLISHED MEASURES AND FACILITIES FOR THE AUTHORIZED ECONOMIC OPERATOR BY DIGESA AND THE DIGEMID, UNDER SUPREME DECREE NO. 267-2020-EF
On July 12, 2022, Supreme Decree N° 013-2022-SA was published in the Official Gazette "El Peruano", which establishes measures and facilities for the economic operator authorized by the “Dirección General de Salud Ambiental e Inocuidad Alimentaria” and the “Dirección General de Medicamentos, Insumos y Drogas”, within the framework of Supreme Decree N° 267-2020-EF.
A DEADLINE IS GRANTED TO SUPPORT THE EFFECTIVENESS AND SAFETY OF THE PHARMACEUTICAL SPECIALTIES INCLUDED IN THE SECOND TRANSITIONAL SUPPLEMENTARY PROVISION OF SUPREME DECREE NO. 016-2013-SA
On July 5, 2022, Supreme Decree N° 012-2022-SA was published in the Official Gazette "El Peruano", which grants a term to support the efficacy and safety of the pharmaceutical specialties included in the Second Transitory Complementary Provision of Supreme Decree N° 016-2013-SA.
ARTICLES OF THE REGULATION FOR THE REGISTRATION, CONTROL AND SANITARY VIGILANCE OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND SANITARY PRODUCTS, APPROVED BY SUPREME DECREE N° 016-2011-SA, ARE MODIFIED
On June 30, 2022, Supreme Decree N° 011-2022-SA was published in the Official Gazette "El Peruano", which approves the modification of Article 40 and Article 104 of the Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceuticals, Medical Devices and Medical Devices, approved by Supreme Decree N° 016-2011-SA.